NDC 68400-357

Gelato Topical Anesthetic

Benzocaine

Gelato Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. The primary component is Benzocaine.

Product ID68400-357_d7033fbb-6b0c-4ac5-e053-2a95a90a7661
NDC68400-357
Product TypeHuman Otc Drug
Proprietary NameGelato Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2018-06-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68400-357-30

30 g in 1 JAR (68400-357-30)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68400-357-30 [68400035730]

Gelato Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:80182c43-100f-4b15-a07e-819599ab9562
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910
  • 727988

    • NDC Crossover Matching brand name "Gelato Topical Anesthetic" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    68400-355Gelato Topical AnestheticGelato Topical Anesthetic
    68400-351Gelato Topical AnestheticGelato Topical Anesthetic
    68400-350Gelato Topical AnestheticGelato Topical Anesthetic
    68400-352Gelato Topical AnestheticGelato Topical Anesthetic
    68400-356Gelato Topical AnestheticGelato Topical Anesthetic
    68400-323Gelato Topical AnestheticGelato Topical Anesthetic
    68400-354Gelato Topical AnestheticGelato Topical Anesthetic
    68400-359Gelato Topical AnestheticGelato Topical Anesthetic
    68400-357Gelato Topical AnestheticGelato Topical Anesthetic
    68400-353Gelato Topical AnestheticGelato Topical Anesthetic
    68400-358Gelato Topical AnestheticGelato Topical Anesthetic
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE
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